Effect Of Pathyadi Kwatha In Dysfunctional Uterine Bleeding(Asrigdara)

Phase 3

Not yet recruiting

• Conditions: Abnormal uterine and vaginal bleeding, unspecified. Ayurveda Condition: ASRUGDARAH/RAKTAPRADARAH,

• Registration Number: CTRI/2023/10/058721
• Lead Sponsor: Dr Komal T Gayakwad

Brief Summary

- *Asrigdara*is one among the *Raktapradoshaja vikara*& is characterized by *Artava atipravrutti,Deerghakala pravrutti,Anruta kala pravrutti* associated with *Angamard*and *Savedana Artava pravrutti.*

- It is similar to Dysfunctional Uterine Bleeding (DUB), characterized by excessive  bleeding without any known pelvic pathology

- In this study Pathyadi Kwatha is selected as trial drug  for the management of Asrigdara(DUB) and its efficacy is compared with Dhataki-Puga Pushpa Kwatha.

- This is a randomized controlled clinical trial. Total 40 patient of Asrigdara who fulfill the inclusion criteria & diagnostic criteria based on clinical sign and symptoms of Asrigdara will be selected

- Total Study duration will be 90 days and contain 6 visits (every 4th and 10th day of 3 comsecutive menstrual cycle), which includes administration of trial drug for 7days for two consecutive cycle and post medication follow up on 4th and 10th day of 3rd menstrual cycle.

- After study, data will be collected from case report form (CRF) and statistically analyzed by using appropriate parametric and non-parametric tests and results will be obtained. On that basis results and conclusion will be drawn.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-03-10
• Study Start: 2023-10-16

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• 1.Pratyatma lakshana of Asrigdara and DUB.
• Asrigdara-Artava deergha kala Pravritti, Artava Ati Pravritti, Anruta kala Pravritti.

Exclusion Criteria

• 1.K/C/O – Diabetes mellitus, hypertension, tuberculosis.
• 2.Patient using intra uterine contraceptive device 3.K/C/O-Coagulation disorders 4.Patient with severe anemia HB% below 8 gms 5.K/C/O- Any pelvic pathology.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Effect of trial drug on improvement in the symptoms of Asrigdara(DUB).	4th day of menses, 10th day for three consecutive cycle

Secondary Outcome Measures

Name	Time	Method
Safety of the trial drug & Adverse Drug reaction & Aggravation in the symptoms of Asrigdara(DUB)	4th day of menses, 10th day for three consecutive cycle

Trial Locations

Locations (1)

Padma Ayurvedic Hospital And Research Centre; 🇮🇳 Bagalkot, KARNATAKA, India

Padma Ayurvedic Hospital And Research Centre

🇮🇳Bagalkot, KARNATAKA, India

Dr Komal T Gayakwad

Principal investigator

8088236627

drkomalgayakwad10@gmail.com